Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A ProspectiveSingle-centerRandomizedControlled Study to Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single anastomosis sleeve ileal bypass SASI is an improved surgical technique for sleeve gastrectomy SG which combines the advantages of SG and Roux-en-Y gastric bypass RYGB while avoiding their disadvantagesin order to achieve better treatment outcomesOn the one handSASI surgery improves the effectiveness of weight loss surgery by adding gastrointestinal anastomosis on the basis of SGwhile reducing gastric pressure and improving postoperative gastroesophageal reflux symptomsOn the other handit also avoids the regret of RYGB surgery leaving the stomach open for gastroscopy examination and reduces the risk of postoperative nutrition related complicationsThereforeSASI surgery has demonstrated good application prospects and is expected to be promoted in clinical practiceSo farthere has been no comparative study of RCTs between RYGB and SASI internationallyIn order to compare the weight loss effects of SASI and RYGB surgerythis study intends to conduct a randomized controlled trial on patients who meet the criteria and require weight loss surgeryproviding high-level evidence-based medicine for the further clinical development of SASI surgery in the future
Detailed Description:
Routine preoperative examinations should be conducted on patients planning to undergo weight loss surgeryand inclusion screening should be conducted according to the inclusion and exclusion criteriaPatients who meet the inclusion criteria will receive informed consent before enrollment and be randomly assigned to either the experimental group SASI group or the control group RYGB group for weight loss surgery based on computer randomization results
Monitor the patient39s surgical condition and surgical complications before discharge
Follow up will be conducted at each follow-up node after surgery 1 month3 months6 months12 months
This study aims to measure the weight of patients before and after surgery analyze the degree of weight loss based on the percentage of excess weight loss EWL one year after surgery and compare the weight loss effects of two surgical proceduresAt the same timebased on relevant laboratory resultsthe effectiveness of two surgical procedures for treating metabolic syndromethe incidence of postoperative nutritional complicationsthe incidence of surgical related complicationsthe quality of life one year after surgeryand weight loss were compared
Monitor the patient39s surgical condition and surgical complications before discharge
Follow up will be conducted at each follow-up node after surgery 1 month3 months6 months12 months
This study aims to measure the weight of patients before and after surgery analyze the degree of weight loss based on the percentage of excess weight loss EWL one year after surgery and compare the weight loss effects of two surgical proceduresAt the same timebased on relevant laboratory resultsthe effectiveness of two surgical procedures for treating metabolic syndromethe incidence of postoperative nutritional complicationsthe incidence of surgical related complicationsthe quality of life one year after surgeryand weight loss were compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None